Abstract: The present disclosure relates to a stable multiparticulate composition comprising coated discrete units of an amine drug or a pharmaceutically acceptable salt thereof with stabilizing amount of one or more nitrite quencher. The composition provides effective control of the level of nitrosamine drug substance related impurities (NDSRIs) in the drug product during shelf life of the product.
| # | Name | Date |
|---|---|---|
| 1 | 202517033312-STATEMENT OF UNDERTAKING (FORM 3) [04-04-2025(online)].pdf | 2025-04-04 |
| 2 | 202517033312-PROOF OF RIGHT [04-04-2025(online)].pdf | 2025-04-04 |
| 3 | 202517033312-PRIORITY DOCUMENTS [04-04-2025(online)].pdf | 2025-04-04 |
| 4 | 202517033312-POWER OF AUTHORITY [04-04-2025(online)].pdf | 2025-04-04 |
| 5 | 202517033312-NOTIFICATION OF INT. APPLN. NO. & FILING DATE (PCT-RO-105-PCT Pamphlet) [04-04-2025(online)].pdf | 2025-04-04 |
| 6 | 202517033312-FORM 1 [04-04-2025(online)].pdf | 2025-04-04 |
| 7 | 202517033312-FIGURE OF ABSTRACT [04-04-2025(online)].pdf | 2025-04-04 |
| 8 | 202517033312-DECLARATION OF INVENTORSHIP (FORM 5) [04-04-2025(online)].pdf | 2025-04-04 |
| 9 | 202517033312-COMPLETE SPECIFICATION [04-04-2025(online)].pdf | 2025-04-04 |
| 10 | 202517033312-CLAIMS UNDER RULE 1 (PROVISIO) OF RULE 20 [04-04-2025(online)].pdf | 2025-04-04 |
| 11 | 202517033312-MARKED COPIES OF AMENDEMENTS [07-04-2025(online)].pdf | 2025-04-07 |
| 12 | 202517033312-FORM 18 [07-04-2025(online)].pdf | 2025-04-07 |
| 13 | 202517033312-FORM 13 [07-04-2025(online)].pdf | 2025-04-07 |
| 14 | 202517033312-AMMENDED DOCUMENTS [07-04-2025(online)].pdf | 2025-04-07 |
| 15 | 202517033312-FORM-9 [02-06-2025(online)].pdf | 2025-06-02 |
| 16 | 202517033312-FORM 3 [01-10-2025(online)].pdf | 2025-10-01 |